Cardiovascular Systems to Unveil New Data from Confirm Study Series at NCVH Conference

Subanalysis of procedural events within claudicant, CLI, and renal disease patient populations treated with orbital atherectomy for peripheral arterial disease

Cardiovascular Systems to Unveil New Data from Confirm Study Series at NCVH Conference

Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), will share new data from its CONFIRM study series at the 2013 New Cardiovascular Horizons (NCVH) conference in New Orleans.

The CONFIRM series of patients evaluated the use of CSI’s orbital atherectomy system as a treatment for peripheral arterial disease (PAD) —in above- and below-the-knee lesions— in a real world population of patients (with no exclusions). Eighty-one percent of the lesions treated had severe or moderate calcification—historically considered a difficult patient population to treat. CONFIRM, like other studies in CSI’s growing body of clinical research, is aimed at providing physicians with scientific data to make sound treatment decisions.

The following posters will be featured at NCVH, Wednesday, June 5, through Friday, June 7, from 7:30 a.m. to 6 p.m.:

Visit CSI at booth #104 7:30 a.m. – 6 p.m. Wednesday, June 5, through Friday, June 7, to meet the company’s calcium experts and learn more about its unique orbital technology.

As many as 8 million to 12 million Americans, most over age 65, suffer from PAD, which is caused by the accumulation of plaque in peripheral arteries (commonly the pelvis or leg) reducing blood flow. Symptoms include leg pain when walking or at rest. Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing faster than the rest of the population.

Millions of patients with PAD may benefit from treatment with orbital atherectomy utilizing the Stealth 360° and Diamondback 360°, minimally invasive catheter systems developed and manufactured by CSI. These systems use a diamond-coated crown, attached to an orbiting shaft, which sands away plaque while preserving healthy vessel tissue — a critical factor in preventing reoccurrences. Balloon angioplasty and stents have significant shortcomings in treating hard, calcified lesions. Stents are prone to fractures and high recurrence rates, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results.

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. FDA granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in August 2007. To date, nearly 110,000 of CSI’s devices have been sold to leading institutions across the United States. CSI has also completed its ORBIT II Investigational Device Exemption clinical trial to evaluate the safety and effectiveness of its orbital technology in treating coronary arteries. The coronary system is limited by federal law to investigational use and is currently not commercially available in the United States.

For more information, visit the company’s website at .

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